ArticleIndian heart journal
The 'all comer' Coroflex Please drug-eluting stent registry in Europe and Asia - an overall and transcontinental assessment of the 10-month major adverse cardiac events.
Article in Indian heart journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Trial
- A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).Frontiers in cardiovascular medicine · 2023Article
- Polymer-free sirolimus-eluting stent use in Europe and Asia: Ethnic differences in demographics and clinical outcomes.PloS one · 2020Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRandomized trials assess the potential of a medical device in well defined indications while "all comer studies" reveal the device performance in the real clinical environment.
aimsThis 'all comers' registry assessed the 10-month outcome of the Coroflex(®) Please drug-eluting stent in Europe and Asia by clinically driven major adverse cardiac events.
methodsThe Coroflex(®) Please Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were technical success, in-hospital outcomes, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) for subgroup analyses.
resultsOf the enrolled 1230 patients (63.6 ± 11.2 years, 33.9% diabetics), 339 (27.6%) had an acute coronary syndrome, 148 (12.1%) STEMI and 191 (15.6%) NSTEMI. After 10.5 ± 3.8 months (follow-up rate 92.8%), the target lesion revascularization rate (TLR) was 7.8% overall, 8.3% in STEMI, and 11.3% in NSTEMI patients. Total MACE was 11.1% and significantly higher in ACS with either diabetes mellitus (22.9%, p = 0.017) or age ≥75 years (25.4%, p = 0.026). In European and Asian patients MI rates (5.2% vs 3.1%, p = 0.135) and cardiac death rates (1.6% vs 0.9%, p = 0.414) were similar. The MACE rate was higher in Europe (13.6% vs 4.7%, p < 0.001) driven by a six times higher TLR rate.
conclusionsTLR and MACE occurred within the range of previously published data. The incidence of MI and cardiac death were not different between Europe and Asia. MACE were higher in Europe driven by target lesion revascularization.
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